Phase II Study of Pegylated Ifná-2a (Pegasys) in Patients With Chronic Myeloid Leukemia Who Have Minimal Residual Disease While Receiving Therapy With Tyrosine Kinase Inhibitors
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive Pegasys through
a needle under the skin 1 time each week while you are on study. You will be taught how to
use the study drug at the first visit and will administer it to yourself at all future
You will continue receiving the TKI you are already taking at the dose and frequency you
have been receiving it when you began taking part in this study.
At every study visit, you will be asked about any side effects you may have had and to list
any drugs you may be taking.
Every 1-2 weeks for 8 weeks, then every 6-8 weeks after that, blood (about 1-2 teaspoons)
will be drawn for routine tests.
Every 3 months for 6 months, then every 6-12 months after that, you will have a complete
physical exam, including measurement of your vital signs.
Every 3-6 months for 1 year, you will have a bone marrow aspirate to check the status of the
disease and to check for changes in your chromosomes.
Every 3-6 months for 1 year, then every 6-12 months after that, blood (about 1 teaspoon)
will be drawn to check the levels of leukemia in the blood.
Length of Study:
You may continue taking Pegasys for as long as the doctor thinks it is in your best
interest. You will no longer be able to take the study drug if the disease gets worse, if
intolerable side effects occur, or if you are unable to follow study directions.
This is an investigational study. Pegasys is FDA approved and commercially available for
the treatment of CML. TKIs (imatinib, nilotinib, and dasatinib) are FDA approved and
commercially available for the treatment of CML. The combination of these drugs to treat CML
Up to 50 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants Achieved of Major Molecular Response (MMR) or Complete Molecular Response (CMR)
Molecular response defined as: major molecular response (MMR) corresponds to a BCR-ABL1/ABL1 ratio of <=0.01. Complete molecular response (CMR) is defined as undetectable BCR-ABL1 transcripts. Molecular response measured every 3 months (a total of 4 assessments within one year of therapy).
12 months from start of treatment with PEG-IFNá-2a
Alfonso Quintas-Cardama, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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